Method of using a needle shield device for surgical packages

ABSTRACT

A method of using a needle shield for retainers enclosing suture-needle assemblies constructed of a fibrous material and foldable about at least two score lines to provide a protective device against needle damage, accidental sticking of the user&#39;s fingers, and puncture of the package within which the retainer is packaged.

This is a divisional of U.S. application Ser. No. 08/055,959 filed Apr.30, 1993, now U.S. Pat. No. 5,358,102 which is a continuation ofapplication Ser. No. 07/852,686 filed on Mar. 17, 1992, now abandoned,which is a continuation-in-part of application Ser. No. 07/636,227 filedDec. 31, 1990, now U.S. Pat. No. 5,236,082.

Background of The Invention

1. Field of the Invention

The present invention relates to surgical suture-needle packages, andmore particularly to a needle shield device for protecting the tip ofthe needles from damage and to eliminate the possibility of accidentalsticking of a person's finger by the needles, as well as to preventpuncturing of the sterile package in which the needles are enclosedduring storage and handling.

2. Discussion of the Prior Art

packaging,devices for needles and suture needle assemblies which includeprotective flaps or covers are well known in the art. These packagesgenerally include a fold over flap or cover which encloses the needlesor the needle tips in the package. In many cases, the flap is integrallyformed as part of the package so that the flap or cover comprises a tearaway portion which exposes the needles upon opening of the package.

The packaging of sutures, particularly sutures having a needlepositioned on at least one end of the suture, requires specialconsideration to eliminate the possibility of puncturing of the sterilepackage by the needle enclosed therein, as well as to protect a surgeonor surgical team member from accidental sticking during handling whileopening the package. It is also desirable to protect the needlesthemselves after the package is open against damage to the tips.

Typically, the suture is wound on a retainer prior to enclosure within asterile, moisture-impervious outer package. The retainer may compriseany containment device, and generally is constructed of a fibrous,somewhat rigid material such as paperboard, pressed paper, or acardboard material. The retainer may be formed as a series of panelswhich are foldable over each other to secure the suture between thepanels. In most cases, the needles are either loosely positioned betweenthe panels or latched to a panel and folded between the panels with thesutures. Examples of retainers which fold a series of panels over ontothemselves to secure the sutures and needles therebetween are disclosedin U.S. Pat. No. 3,136,418 to Stacy et al. and U.S. Pat. No. 3,939,969to Miller et al.

Another type of suture retainer is constructed as a two piece devicehaving a molded plastic bottom tray which includes a coiled passageway.The suture lays in the passageway, and the entire tray is covered by atop cover or layer of a sheet-like material. When needles are providedon the sutures, the needles are usually secured outside the retainer;that is, the sutures are in the passageway of the bottom tray andcovered by the top sheet, while the needles are external to the retainerand must be secured by some additional means. Usually, the needles arepositioned in a holding member such as a foam needle park. An example ofsuch a retainer is disclosed in U.S. Pat. No. 3,338,401 to Regan, Jr.

In order to maintain the sterility of such a device, the retainer havingthe needles attached thereto are further packaged in amoisture-impervious package, constructed of metal foil, plastic film orother suitable materials. A disadvantage to this arrangement lies in thefact that the sharp needles directly rest against the inner surface ofthe outer package, and may puncture the outer package during storage,handling, etc. This will of course destroy the sterility of the sutureand needle assembly, and may expose the surgeon or surgical assistant toa hazard involving accidental sticking.

Several tear away type needle covers for use with surgical suture-needleassembly packages are provided in the prior art. These packagesgenerally comprise a panel having either perforations or score lineswhich facilitate tearing a portion of the panel from the package toexpose the needles after the package is opened. After the tear awaycover or flap is removed, the needle and suture assembly may be removedfrom the package in the conventional manner.

In the prior art, several packages having tear away cover flaps aredisclosed, such as U.S. Pat. No. 4,063,638 to Marwood. The packagedisclosed in Marwood comprises a three panel package, where the sutureis wound and held at the center panel and the needle is held in an outerpanel. A panel having the tear away flap is provided on the outer panelopposite the needle retaining panel, and the tear away flap is foldedover the sutures followed by the needle retaining flap. Upon opening thepackage, the flap is torn away, thus revealing the needle so that theneedle may be removed in the conventional manner.

Another type of package prevalent in the prior art provides a fold overflap which covers the needles within the package. When the package isopened, the fold over flap is unfolded to reveal the needles so that theneedles may be removed in the conventional manner. Such a device isdisclosed in U.S. Pat. No. 4,574,948 to Huck et al. Huck et al. providesa packaging device in which the suture is secured on one panel of thepackage and the needles are secured on a second panel. A fold over flapis provided to cover the needles to prevent sticking of the user and toprevent damage to the needle tips. As the package is opened, the foldover flap is unfolded to reveal the needles so that the needles may beremoved in a conventional manner. A similar type device is disclosed inU.S. Pat. No. 4,708,241 to Black, deceased.

The devices disclosed in the prior art suffer from several disadvantagesin which the risk of accidental sticking of the needle into the fingersof the user is not significantly reduced or eliminated, and further,many of these devices suffer the disadvantage in that the cost ofpackaging is increased due to the necessity for additional packagingmaterial as well as increasing the number of packaging steps duringassembly.

Surgical suture-needle retainers and needle packages are generallyconstructed of a material which resists folding and bending and which isstrong enough to hold a coiled suture in place without the risk of thesuture unraveling during shipment. The retainer must also be rigidenough to resist bending or folding to eliminate the risk of creasingthe suture during shipment, so that when the retainer is opened thesuture may be removed from the package without creases or bends. Thereis significant emphasis in the surgical suture industry placed on the"memory" retention of the suture material, so that the suture retainsits original shape upon removal from the retainer with a minimum ofbends and creases, even after extended periods of time within theretainer. In view of this, many of the retainers disclosed above whichprovide a needle retaining member which is folded over the packageincrease the amount of bends in the suture material during packaging,which may lead to an undesirable suture-needle assembly upon removalfrom the retainer.

A further disadvantage of the prior art retainers is that in using theretainer itself to protect the needles, such as those retainersdisclosed above having a tear away portion, there is a requirement thatadditional packaging material must be provided to cover the needle.Given the fact that many of these retainers employ rigid panels,sometimes in laminate form, the cost of packaging is necessarilyincreased to provide the needle cover. In addition, the step of formingthe retainer material must include the addition of score lines orperforations to facilitate the tear feature to expose the needles.

An additional disadvantage to these fold over devices lies in the facethat the needles are hidden from view until that portion of the retaineris either torn away or unfolded to reveal the needles. Consequently, theuser is at risk of accidentally sticking himself with the needles sincehe cannot see the needles during the tear away or unfolding step.

The novel needle shield device for surgical retainers and packageshaving needles or suture-needle assemblies of the present inventionobviates the disadvantages encountered in the prior art and provides auniversal needle shield device for use with any surgical needle orsuture-needle retainer or package. The shield of light weight materialand provides the user with protection against sticking while furtherproviding protection for the needle tips against damage. The shieldfurther protects the outer sterile package in which the retainer isenclosed from inadvertent puncture. The needle shield of the presentinvention may be used with any surgical needle or suture-needle assemblypackage, and eliminates the requirement for providing additionalpackaging material and the requirement for complex folding arrangementsof the rigid retainer material to cover the needles.

SUMMARY OF THE INVENTION

The present invention provides a novel needle shield device for surgicalsuture and needle retainers and packages having needles or suture-needleassemblies packaged therein. The device may also be used with syringesor hypodermic-type needles to protect the needle and to guard againststicking during opening of the package, by allowing the user to view theneedle during the opening procedure so that the user knows at all timeswhere the sharp tips of the needles are located.

The needle shield of the present invention essentially comprises a sheetof fibrous material which is attachable to a cover panel of the needleor suture-needle assembly retainer in the vicinity of the tips of theneedles, and is preferably secured by adhesives, glue or the like.

The needle shield of the present invention has a substantiallyrectangular shape, and is provided with a series of score lines or foldlines along the edges of the rectangle from which outwardly directedprojections extend from the needle shield, and it is at this locationthat the needle shield is secured to the cover panel of the retainer.Preferably, an adhesive-backed foam needle park or holder is securedacross the fork-like projection and then is secured directly to theretainer in the area of the needle tips. The spaces between thefork-like projections allow the adhesive-backed needle park to. adhereto the cover panel of the retainer. In this manner, the needles areretained in the needle park so that their tips lie on the fibrousmaterial which forms the needle shield.

Intermediately spaced between the edge having the fork-like projectionsand the opposite parallel edge, is a scored line which forms a firstfold line of the needle shield and which is parallel to the edge formingthe forked projections. Preferably, two additional scored fold lines areprovided which are perpendicular to the first scored line and the edgeof the device having the forked projections. It is these two scoredlines, preferably parallel to each other, which form the side edges ofthe needle shield. Wing-like projections having generally semi-circularor triangular shapes extend outwardly from the scored lines which arefolded about the body of the shield in a manner described below.

The retainers with which the needle shield of the present invention isused may be any type of retainer for holding a suture and needlecombination, where the needles extend outside the retainer while thesuture is secured within. The retainer may comprise a plurality offoldable panels, including a suture winding panel, a bottom panel and acover panel. In its simplest form, the retainers includes a bottom paneland a cover panel, with the suture positioned between the panels, andthe needles located outside the retainer adjacent the cover panel.

In addition the retainer may be of the molded-tray type in which thebottom cover of the retainer is provided with at least one curvedpassageway which accommodates the suture. A cover panel, which maycomprise any sheet-like material such as pressed paper, cardboard,plastic, or spun bonded polyolefin fibers (known as Tyvek, a registeredtrademark of DuPont), overlies the bottom stay and is secured about itsperiphery to the bottom tray. The cover panel is preferably providedwith at least one aperture through which the sutures extend so that theneedles are positioned outside the retainer adjacent the cover panel.

In use, the foam needle park is positioned across the fork projectionsand the needle shield and foam park are adhered to the cover panel ofthe retainer adjacent the needles. The needles are then positioned inthe needle park so that the tips of the needles lie on the needleshield. The shield is then folded over itself at the first scored line,to wrap the body of the shield about the needle tips. The wing-likeprojections are then folded along the perpendicular side score linesunder the bottom of the sheet to hold the needle shield about the needletips.

The retainer and needle shield are then inserted into an outer sterilepackage which may be a metal foil pouch or a so-called "breather-pouch"having a plastic film overlying a Tyvek layer. The needle shieldprotects the outer package by eliminating the possibility of puncturingof the package due to the shield fully enclosing the sharp-tippedneedles. This is important to maintain sterility of the suture-needleassembly, as well as to prevent drying out of the suture, particularlyif the suture is a gut-type or collagen-type suture which requirespackaging in a conditioning fluid medium to maintain its suppleness.

It is also contemplated that the needle shield be provided with an endguard member which comprises a projection which extends upwardly fromthe edge of the needle shield opposite the fork projections so that whenone of the side wing-like extensions is folded under the needle shield,the fold line extends through this projection so that the shield iswrapped about the suture-needle connection point of the endmostsuture-needle assembly, to prevent puncture of the outer package at thebutt-end of the needles.

The present invention provides a needle shield which may be used withany type of needle retainer package, whether the needles be for use in asuture-needle assembly, a hypodermic-type syringe needle, or the like.The fibrous material which comprises the needle shield is preferably amaterial such as Tyvek, which is constructed of polyolefin fibers whichare bonded by heat and calendar pressure. While this is the preferredmaterial, other, similar fibrous material such as pressed paper orfiberboard are also contemplated for use as the needle shield of thepresent invention. The scored fold lines may also be perforated lineswhich may facilitate easier folding and unfolding.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention will become more readily apparentand may be understood by referring to the following detailed descriptionof an illustrative embodiment of the needle shield for surgical sutureretainers and its novel construction, taken in conjunction with theaccompanying drawings in which:

FIG. 1 illustrates a top plan view of a needle shield according thepresent invention;

FIG. 2 illustrates the needle shield of FIG. 1 positioned on asuture-needle retainer in the open position to reveal the needles of theretainer;

FIG. 3 illustrates the needle shield of FIG. 2 in the closed retainer;

FIG. 4 illustrates a top plan view of an alternate embodiment of theneedle shield of the present invention;

FIG. 5 illustrates the needle shield of FIG. 4 positioned on asuture-needle retainer in the open position;

FIG. 6 illustrates the needle shield of FIG. 5 positioned on asuture-needle retainer in the fully closed position;

FIG. 7 illustrates a top plan view of a further embodiment of the needleshield of the present invention;

FIG. 8 illustrates the needle shield of FIG. 7 in position on asuture-needle retainer in the open position;

FIG. 9 illustrates the needle shield of FIG. 8 in position on asuture-needle retainer in the closed position;

FIG. 10 illustrates a perspective top view of a retainer having theneedle shield of the present invention attached thereto;

FIG. 10A illustrates a bottom plan view of the retainer of FIG. 10; and

FIG. 11 illustrates the retainer and needle shield of FIG. 10 enclosedin an outer package.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now in specific detail to the drawings, in which likereference numerals identify similar or identical elements throughout theseveral views, FIG. 1 shows the needle shield 10 of the presentinvention. Needle shield 10 comprises a flat sheet of fibrous material,preferably a non-woven fibrous sheet such as Tyvek which comprises spunbonded polyolefin fibers pressed together to form a sheet of fibrousmaterial. While it is contemplated in the preferred embodiment thatneedle shield 10 be constructed of Tyvek, it is clear that any fibrousmaterial may satisfy the requirements for protecting packaged needlesfrom damage and eliminating the possibility of accidental sticking of aperson's finger by the needles, as well as preventing puncture of theouter packages from the sharp needles.

The body portion 12 of needle shield 10 is provided with a series offork-like projections 14 which extend outwardly from body 12 and arespaced from each other as shown. A score line 18 is provided on body 12which essentially separates body 12 into two halves. Bottom half 16 andtop half 20 are described in more detail in relation to FIGS. 2 and 3.

Wing-like projections 22 and 26 extend outwardly from body 12 and arefurther defined by score line 24 which allows projection 22 to be foldedonto body 12, and score line 28 which allows projection 26 to belikewise folded. A third projection 30 is provided along the edge of topsheet 20 opposite the edge defined by score line 18. Projection 30 willbe described in more detail below in reference to FIGS. 2 and 3.

Turning now to FIG. 2, a suture-needle retainer 32 is shown havingneedle shield 10 positioned on cover panel 33. As best seen in FIGS. 10and 10A, retainer 32 includes top or cover panel 33 and bottom panel 39.Bottom panel 39 may comprise a molded tray having at least one curvedpassageway molded therein for holding at least one suture. Preferablythe curved passageway is arranged in a spiral coil. Top or cover panel33 comprises a sheet of material, constructed of paper, paperboard,plastic or preferably Tyvek, and is secured about the periphery ofbottom panel 39. Cover panel 33 is provided with at least one aperture31, through which sutures 34b extend so that needles 34a are locatedoutside retainer 32.

Needle shield 10 is preferably secured to cover panel 33 of retainer 32in the vicinity of needle assemblies 34, so that the tips of the needlesrest on bottom sheet 16 as seen in FIG. 2. To secure needle shield 10 toretainer 32, any adhesives or glue materials may be used. However, it ispreferred that an adhesive backing needle holding member, such as foamneedle park 36 be provided to secure needle shield 10 to cover panel 33of retainer 32. Needle park 36 is provided with an adhesive backingwhich secures the needle shield 10 to the back of needle park 36 atprojections 14. The spacing between projections 14 allows the needlepark to be further secured to cover panel 33 of retainer 32 so thatneedle shield 10 is secured to the retainer between cover panel 33 andfoam needle park 36. Needle park 36 also provides a means for holdingthe needles 34a in position, which assists needle shield 10 inprotecting the tips of the needles from damage and the outer packagefrom puncture, as well as to protect a user from accidental sticking.

In use, after needle shield 10 has been secured to cover panel 33 ofretainer 32 through needle park 36, needles 34a are secured in needlepark 36 so that the tips of the needles rest on bottom sheet 16 as shownin FIG. 2. Needle shield 10 is then folded on score line 18 so that topsheet 20 covers the tips of the needles as shown in FIG. 3. Needleshield 10 is so dimensioned that the upper edge of top sheet 20 engagesthe front edge of needle park 36 to completely enclose the tips of theneedles. At this point, wing-like projections 22 and 26 are folded alongscore lines 24 and 28, respectively, and tucked under bottom sheet 16 tohold needle shield 10 in place. Projection 30 is provided to cover thesuture connection to the endmost needle 34a as best seen in FIG. 3.Finally, top flap 38 of suture retainer 32 is folded at perforated line35 over the suture ends of needle assemblies 34 to completely enclosethe needles as shown in FIG. 3. A second perforated line 37 is providedto allow the top flap 38 and upper portion of suture retainer 32 to befolded over in the open position to provided 360° access to the needles34 from the front or back of the retainer, so that the needles may beremoved from either side of the retainer.

Turning now to FIG. 4, needle shield 40 is an alternate embodiment ofneedle shield 10 of FIG. 1. A sheet of fibrous material 42 is providedhaving fork-like projections 44 which are spaced from each other asshown. A score line 48 is provided to allow sheet 42 to be folded overitself in much the same manner as shown in relation to FIG. 1. Foldingneedle shield 40 along score line 48 provides a bottom sheet 46 and atop sheet 50, where top sheet 50 has wing-like projections 52 and 56which are defined by score lines 54 and 58, respectively. A furtherprojection 60 is provided along the upper edge of top sheet 50 andprojection 60 will be described further below in reference to FIGS. 5and 6.

As best seen in FIG. 5, needle shield 40 is positioned on a cover panel63 of suture-needle retainer 62 in the vicinity of needles 64. Package62 is identical to package 32 described above and shown in FIGS. 10 and10A, and includes top or cover panel 63 and a bottom tray-type panel 69over which cover panel 63 is secured. Cover panel 63 is provided with atleast one aperture 61, so that sutures 64b, positioned between panels 63and 69, extend through aperture 61 and terminate in needles 64. Needleshield 40 is secured to cover panel 63 of retainer 62 through theprovision of an adhesive backed foam needle park 66 which is similar toneedle park 36 as shown in FIG. 2. As above, needle shield 40 is securedto cover panel 63 of the retainer between the adhesive backed needlepark 66 and the face of cover panel 63, where the needle park 66 securesshield 40 to cover panel 63 to hold fork-like projections 44 in place.Needles 64 are then secured in needle park 66 as seen in FIG. 5.

In use, after the sutures are placed in retainer 62 and extend throughaperture 61, needle shield 40 is secured to retainer 62 at cover panel63. Needles 64 are positioned in needle park 66 so that the tips ofneedles 64 rest on bottom sheet 46. Needle shield 40 is then folded atscore line 48 so that top sheet 50 covers the needle tips which are nowpositioned between top sheet 50 and bottom sheet 46. As seen in FIG. 6,score line 48 is so positioned that when needle shield 40 is folded atscore line 48, the upper edge of top sheet 50 completely covers needlepark 66. At this point, wing-like projections 52 and 56 are folded onscore lines 54 and 58, respectively, and tucked under bottom sheet 46 tosecure the needle shield. As been seen in FIG. 6, upper projection 60provides a protective cover for the suture end of endmost needle 64a.Finally, top flap 68 of retainer 62 is folded over the suture ends ofthe needles 64 to completely enclose the needles as shown.

Turning now to FIG. 7, a further alternate embodiment of the needleshield is shown. Needle shield 70 is constructed of a sheet of fibrousmaterial 72 having fork-like projections 74 which are spaced from eachother along top edge 84. A score line 78 is provided which allows sheet72 to be folded over on itself to define bottom sheet 76 and top sheet80. A wing-like projection 86 is provided which is foldable about scoreline 88 which will be described below.

As best seen in FIG. 8, needle shield 70 is positioned on asuture-needle retainer 90 which is identical to retainer 32 describedabove and shown in FIG. 10. The shield 90 secures to cover panel 93through the provision of an adhesive backed foam needle park 96. Foamneedle park 96 secures needle shield 70 to cover panel 93 of retainer 90in much the same manner as described above in reference to FIGS. 2 and5. In this embodiment, upper edge 84 is positioned at an angle to scoreline 78, and needle park 96 is positioned along upper edge 84 to secureneedle shield 70 through fork-like projections 74. After needle shield70 is secured to retainer 90, needles 94, which are attached to thesutures positioned between cover panel 93 and bottom panel 99, and whichextend through aperture 91, are secured in needle park 96 as shown.

In use, after sutures 94b are positioned in retainer 90, needles 94 arepositioned in needle park 96 so that the tips of the needles arepositioned on bottom sheet 76. Needle shield 70 is then folded on scoreline 78 so that the needle tips are positioned between bottom sheet 76and top sheet 80. Edge 82 of top sheet 80 is angled relative to scoreline 78 so that when top sheet 80 is folded onto bottom sheet 76, edge82 is aligned with the edge of foam needle park 96 as best seen in FIG.9. At this point, wing-like projection 86 is folded about score line 88and tucked under bottom sheet 76 to secure the needle shield about theneedle. Flap 92 is then folded down onto the suture ends of the needlesto secure the needles therein while providing a view of the needles asbest seen in FIG. 9.

Turning now to FIG. 11, retainer 32 having needle shield 10 positionedthereon is illustrated and is enclosed in outer package 100. Package 100maintains sterility of the suture-needle assemblies packaged in retainer32, and may comprise a so-called "breather pouch" as illustrated in FIG.11. However, it is apparent that outer package 100 may comprise anyend-use package known in the suture industry, including, but not limitedto, plastic or metal foil pouches which maintain both sterility andprevent evaporation of conditioning fluid media packaged with thesutures.

The benefit of needle shield 10 of the present invention is clearly seenin FIG. 11. Without shield 10, the needle tips would be directlycontacting the inner surface of top sheet 102 of package 100, whichwould increase the possibility of puncture of the sterile package 100.The needle shield 10 protects package 100 from the tips of the needles.

While the invention has been particularly shown and described withreference to the preferred embodiments, it will be understood by thoseskilled in the art that various modifications and changes in form anddetail may be made therein without departing from the scope and spiritof the invention. Accordingly, modifications such as those listed above,but not limited thereto, are to be considered within the scope of theinvention.

What is claimed is:
 1. A method of loading a suture retainer comprisingthe steps of:positioning at least one suture between a first panel and asecond panel of a suture retainer, said suture having a needle securedto at least one end thereof, such that said needle is positioned outsidesaid first and second panels, mounting a needle shield member to one ofsaid first and second panels, positioning said needle on said needleshield member, and folding said needle shield member about said needleto enclose said needle therein.
 2. A method according to claim 1,wherein said step of mounting said needle shield member to one of saidpanels comprises positioning an edge of said shield member between oneof said panels and an adhesive-backed foam needle park.
 3. A methodaccording to claim 2, wherein said step of positioning said needle onsaid shield member comprises securing said needle in said needle park.4. A method according to claim 1, further comprising the step ofenclosing said loaded suture retainer in an outer envelope.